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HLA Fusion Software (Version 2.0.0 SP4.1) (2013-07-29)
- Starting date:
- July 29, 2013
- Posting date:
- September 19, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35699
Recalled Products
HLA Fusion Software (Version 2.0.0 SP4.1)
Reason
HLA Fusion software version 2.0.0 SP4.1, using Luminex Xponent run files, may generate a mis-assignment when using product(s) labtype SSO DNA typing tests - DRB1(Catalogue ID: RSSOH2B1) lots 07b and 008. The HLA Fusion software version 2.0.0 SP4.1 may cause a conversion error on certain probes in the RSSOH2B1 kits giving incorrect test results.
Affected products
HLA Fusion Software (Version 2.0.0 SP4.1)
Lot or serial number
Version 2.0.0 SP4.1
Model or catalog number
- FUSPGR
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES